.0) at Week 52 compared to 69% in the CIMZIA 200 mg every other week treatmen group. Study RA-II showed similar results at Week 24.
Table 6: Radiographic Changes at 6 and 12 months in Study RA-I Placebo + MTX
N=199
Mean (SD) CIMZIA 200 mg + MTX
N=393
Mean (SD) CIMZIA 200 mg + MTX –
Placebo + MTX
Mean Difference
An ANCOVA was fitted to the ranked change from baseline for each measure with region and treatment as factors and rank baseline as a covariate.
mTSS
Baseline 40 (45) 38 (49) --
Week 24 1.3 (3.8) 0.2 (3.2) -1.1
Week 52 2.8 (7.8) 0.4 (5.7) -2.4
Erosion Score
Baseline 14 (21) 15 (24) --
Week 24 0.7 (2.1) 0.0 (1.5) -0.7
Week 52 1.5 (4.3) 0.1 (2.5) -1.4
JSN Score
Baseline 25 (27) 24 (28) --
Week 24 0.7 (2.4) 0.2 (2.5) -0.5
Week 52 1.4 (5.0) 0.4 (4.2) -1.0
Physical Function Response
In studies RA-I, RA-II, RA-III, and RA-IV, CIMZIA-treated patients achieved greater improvements from baseline than placebo-treated patients in physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) at Week 24 (RA-II, RA-III and RA-IV) and atWeek 52 (RA-I).
15 REFERENCES
Best WR, Becktel JM, Singleton JW, Kern F: Development of a Crohn's Disease Activity Index, National Cooperative Crohn's Disease Study. Gastroenterology 1976; 70(3): 439-444
16 HOW SUPPLIED/STORAGE AND HANDLING
Storage and Stability
Refrigerate intact carton at 2 to 8 °C (36 to 46 °F). Do not freeze. Do not separate contents of carton prior to use. Do not use beyond expiration date, which is located on the drug label and carton. Protect solution from light.
Lyophilized Powder for Reconstitution:
NDC 50474-700-62Pack Content Qty. Item
2 Type I glass vials with rubber stopper and overseals each containing 200 mg of lyophilized CIMZIA for reconstitution.
2 2 mL Type I glass vials containing 1 mL sterile Water for Injection
2 3 mL plastic syringes
4 20 gauge luer-lock needles (1 inch)
2 23 gauge luer-lock needles (1 inch)
8 Alcohol swabs
Prefilled Syringe
NDC 50474-710-79
2 alcohol swabs and 2 single use prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle, each containing 200 mg (1 mL) of CIMZIA.
Prefilled Syringe Starter Kit
NDC 50474-710-81
6 alcohol swabs and 6 single use prefilled glass syringes with a fixed 25 ½ gauge thin-wall needle. The Starter Kit contains 3 sets of 2 prefilled syringes to provide sufficient drug supply for the initial 3 induction doses at the start of treatment. Each prefilled syringe contains 200 mg (1 mL) of CIMZIA.
17 PATIENT COUNSELING INFORMATION
See Medication Guide
17.1 Patient Counseling
Advise patients of the potential risks and benefits of CIMZIA therapy. Be sure that patients receive the Medication Guide and allow them time to read it prior to starting CIMZIA therapy and to review it periodically. Any questions resulting from the patient's reading of the Medication Guide should be discussed. Because caution should be exercised in prescribing CIMZIA to patients with clinically important active infections, advise patients of the importance of informing their health care providers about all aspects of their health.
Immunosuppression
Inform patients that CIMZIA may lower the ability of the immune system to fight infections. Instruct patients of the importance of contacting their doctor if they develop any sympto |
